BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3993954 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09035
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE HELIX OF THE LEAD EXCEEDED THE NUMBER OF SPECIFIED TURNS TO EXTEND AND RETRACT AND WAS EXTRINSICALLY BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE LEAD BEING INSERTED INTO THE PATIENT, THE PHYSICIAN EXERCISED THE LEAD SCREW AND IT DID NOT EXTEND. MULTIPLE ATTEMPTS WERE MADE TO EXTEND THE SCREW BUT THE SCREW NEVER EXTENDED. THE LEAD WAS REMOVED FROM THE STERILE PROCEDURE AREA AND WAS NEVER INSERTED INTO THE PATIENT. A NEW LEAD WAS USED TO IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468928 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR